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    Biostatistics. Biostatistics. Document Transcript

    • Biostatistics. Premier Research’s biostatisticians, biostatistical programmers, and pharmacokineticists Case Study: understand that well designed studies with appropriately planned and communicated Providing High Quality Data Analysis data analyses are the key to obtaining clinical trial results that support development of A client contracted the Premier Research your compound or device. biostatistics team to deliver high quality data analysis and communications of Services Benefits study results for a comprehensive drug development program of 17 studies that I Regulatory Statistical Consulting and I Strong technical expertise and experience were submitted for regulatory approval. Representation gives you confidence that your data will be rigorously analyzed and effectively Our team of five biostatisticians and I Integrated Clinical/Statistical nine biostatistical programmers delivered Development Planning communicated for greatest impact seven locked databases over a seven I PK/PD Model Development and Analysis I Significant therapeutic experience ensures week period of time, with top line study greater understanding of the nuances of I Design and Analysis of Clinical Trials results delivered to the sponsor within clinical data in specific indications one week and comprehensive tables, Study Design and Analysis Planning Availability of full-service and stand alone I listings, and graphs delivered within two Statistical Analysis Plans support models tailored to provide an weeks of database lock to support this Sample Size Calculations and Simulations optimal fit to enhance your development drug development program. The work Statistical Methods for Protocol team dynamics included a comprehensive safety analysis, Protocol and CRF Consultation and Review I Our record of successful performance in efficacy analyses of patient reported Randomization Schedules large, complex projects provides assurance outcomes, pharmacokinetic and pharma- of our ability to meet the challenges of codynamic data analyses, and completion Interim Analysis and DMC Support your development program of a Through QT Prolongation (TQT) study. Statistical Programming and Modeling I Broad-ranging expertise and experience The biostatistics team collaborated with Table, Listing and Figure Generation in applied statistical methods provides many colleagues in data operations, medical Statistical Reports (CSR, Manuscripts, IB) options for the effective and cost-efficient writing, and the sponsor to deliver the I Design and Analysis of Observational, analysis of clinical data complete biometrics package for this client Registry, and Rx-to-OTC Switch Studies resulting in a successful approval. I Using our Parallel Processing Approach™, I Health Outcome, Pharmacoeconomic, biostatistical activities are directly integrated and Quality of Life Analyses with staged progress of database set-up, I Large-Scale Data Warehousing and data entry, shell report development and Integration generation of tables, listings and figures I ISS/ISE Planning, Analyses, and e-Submissions I DMC Support and Participation I CDISC Compliant Dataset Development I Manuscript Preparation and Meeting Presentations I Marketing Support FOCUS. EXPERTISE. QUALITY.
    • Biostatistics. Our biostatisticians work with you to determine the optimal cost effective methods for Case Study: collecting, analyzing, and presenting data while maintaining compliance with regulatory Providing Integrated Summary guidelines. Our programmers create customized tables, optimized for unique study designs. of Safety for an NDA The Premier Research biostatistics team Expertise: The People Methods was contracted to provide an Integrated Summary of Safety (ISS) for an NDA I Biostatistics professionals with an average I Descriptive Statistics and Univariate Analyses submission. The timeline for the submission of 10 years in the industry I Linear and Nonlinear Models was four months from contract initiation. I All biostatisticians have advanced degrees Our biostatisticians, collaborating with I Generalized Linear Models/Mixed Linear Models regulatory affairs, data operations, I Technical expertise in biostatistical I Categorical Data Analysis programming and a broad range of applied medical writing, and biometrics project statistical methods I Event Time Distribution Models management, integrated studies from external vendors with the studies com- I Technical expertise in the design, conduct, I Nonparametric Models pleted by Premier Research to complete and analysis of PK/PD, toxicokinetics, and I Imputation Strategies/Sensitivity Analyses the ISS and write the clinical modules for exposure-response study analyses the eCTD NDA for submission. I Non-compartmental and Compartmental I Strong study design and analysis, consulting PK/PD Models This work included meeting with the FDA and communications, and submission in a pre-NDA meeting, weekly meetings experience I Nonlinear Mixed Effects Models (Pop PK) with the sponsor, as well as external vendor I Risk Assessment Models management. Our team of three biosta- Designs I Integrated Summaries and Pooling tisticians and six biostatistical programmers Analysis Methods completed the ISS Statistical Analysis Plan I Frequentist I CDISC Compliant Analysis Data Modules with comprehensive pooling strategies, I Group Sequential and Adaptive (ADaM) development of the CDISC compliant I Equivalence Analysis Data Modules (ADaM), table, listing and figure development, program- I Noninferiority ming and validation, as well as supported I Superiority the medical writing team to complete I Case-control Epidemiology Designs the eCTD clinical modules. The NDA was submitted on-time to the FDA. Premier Research North America: 215.282.5500 Europe: +44 (0) 118 936 4000 info@premier-research.com www.premier-research.com FOCUS. EXPERTISE. QUALITY. Visit our website for our global locations.